FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on July 13, 2022 - 18:18 GMT

American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: COVID Test Kit Nonsterile and Clean Catch Urine Kit Product Codes: JSM Lot Numbers …

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Published on July 11, 2022 - 10:58 GMT

Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2022 - 19:46 GMT

Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on June 30, 2022 - 18:59 GMT

Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

[Posted 06/30/2022] AUDIENCE: Patient, Health Professional, Pharmacy, Oncology ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2022 - 15:41 GMT

Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA ...

Date Issued: June 30, 2022 The U.S. Food and Drug Administration (FDA) is updating the May 2021 Safety Communication to alert the public that Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland is currently …

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Published on June 29, 2022 - 19:12 GMT

Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2022 - 17:07 GMT

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

Date Issued: June 28, 2022 The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or …

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Published on June 28, 2022 - 15:32 GMT

GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use The CARESCAPE R860 ventilator is intended to provide mechanical ventilation or …

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Published on June 23, 2022 - 14:08 GMT

Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Medtronic HVAD Batteries Product Codes: See Recall Database Entry Model Number: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 23, 2022 - 13:22 GMT

Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient …

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Published on June 23, 2022 - 00:18 GMT

BD Announces Voluntary Recall on Intraosseous Products

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

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Published on June 22, 2022 - 21:39 GMT

Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 21, 2022 - 18:00 GMT

Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 21, 2022 - 16:31 GMT

FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for ...

Date Issued: May 17, 2019 Audience: People with diabetes who use continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems to manage their diabetes Health care providers treating or managing patients with …

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Published on June 21, 2022 - 15:04 GMT

UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

On October 28, 2019, the FDA issued a Safety Communication to provide an update on Type III Endoleaks Associated with Use of Endologix AFX Endovascular AAA Graft Systems. October 15, 2018 - The FDA has issued a Class I recall to notify patients and health …

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Published on June 15, 2022 - 00:33 GMT

Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on June 12, 2022 - 13:14 GMT

Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication

Date Issued: December 6, 2022 The U.S. Food and Drug Administration (FDA) is updating our January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA). On December 6, 2022, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 10, 2022 - 03:46 GMT

Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on June 9, 2022 - 18:13 GMT

Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain ...

Summary Company Announcement Date: September 06, 2022 FDA Publish Date: September 06, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description potential risk of serious injury Company Name: Royal Philips’ subsidiary Philips …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 9, 2022 - 16:26 GMT

Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain ...

September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines …

Distribution channels: Healthcare & Pharmaceuticals Industry